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NCT00416832 · CITED IN SOURCE DOCUMENTS

Combination Chemotherapy and Radiation Therapy in Treating Young Patients With Hodgkin's Lymphoma

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE2
Status at capture
COMPLETED
Registry last update
2020-03-26

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill cancer cells. Giving combination chemotherapy together with radiation therapy may kill more cancer cells. PURPOSE: This phase II trial is studying the side effects and how well giving combination chemotherapy together with radiation therapy works in treating young patients with Hodgkin's lymphoma.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part
eligibility Criteria
DISEASE CHARACTERISTICS: * Diagnosis of classic Hodgkin's lymphoma (HL) * Intermediate or advanced disease, including the following stages: * Stage I * Stage IIA, IIB, IIE, or IIBE * Stage IIIA or IIIBE * Stage IV PATIENT CHARACTERISTICS: * No other concurrent malignancies * No severe concurrent diseases (e.g., immune deficiency syndrome) PRIOR CONCURRENT THERAPY: * No prior chemotherapy or radiotherapy * Pre-phase therapy for large mediastinal tumor allowed
healthy Volunteers
false
maximum Age
17 Years
sex
ALL
std Ages
  1. CHILD
Treatment arms and interventions
interventions
  1. name
    cyclophosphamide
    type
    DRUG
  2. name
    dacarbazine
    type
    DRUG
  3. name
    doxorubicin hydrochloride
    type
    DRUG
  4. name
    etoposide
    type
    DRUG
  5. name
    prednisone
    type
    DRUG
  6. name
    procarbazine hydrochloride
    type
    DRUG
  7. name
    vincristine sulfate
    type
    DRUG
  8. name
    radiation therapy
    type
    RADIATION
Study design
primary Purpose
TREATMENT
Enrollment
count
648
type
ESTIMATED
Registered outcome plans (not posted results)
primary Outcomes
  1. measure
    Safety and efficacy
  2. measure
    Reduction of gonadotoxicity
  3. measure
    Quality assurance
Full study description
brief Summary
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill cancer cells. Giving combination chemotherapy together with radiation therapy may kill more cancer cells. PURPOSE: This phase II trial is studying the side effects and how well giving combination chemotherapy together with radiation therapy works in treating young patients with Hodgkin's lymphoma.
detailed Description
OBJECTIVES: * Determine the safety and efficacy of intensified etoposide administered as a part of OEPA combination chemotherapy (vincristine, etoposide, prednisone, and doxorubicin hydrochloride) in pediatric male patients with intermediate or advanced Hodgkin's lymphoma (HL). * Determine the safety and efficacy of COPDIC combination chemotherapy (cyclophosphamide, vincristine, prednisone, and dacarbazine) or COPP combination chemotherapy (cyclophosphamide, vincristine, procarbazine hydrochloride, and prednisone) in reducing gonadotoxicity in male or female patients. * Assess quality assurance of these regimens in pediatric female patients with intermediate or advanced HL. OUTLINE: This is a pilot, multicenter study. Patients are stratified according to disease stage (I or IIA vs IIB, IIE, or IIIA vs IIBE, IIIBE, or IV). * Stratum 1 (stages I or IIA): Male patients receive vincristine IV on days 1, 8, and 15, etoposide IV over 2 hours on days 3-7, oral prednisone on days 1-15, and doxorubicin hydrochloride IV over 4 hours on days 1 and 15 (OEPA). Female patients receive vincristine, prednisone, and doxorubicin hydrochloride as in male patients and oral procarbazine hydrochloride on days 1-15 (OPPA). Both regimens repeat every 4 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients who do not achieve complete remission undergo involved-field radiotherapy beginning 3 weeks after completion of chemotherapy. * Stratum 2 (stages IIB, IIE, or IIIA): Male patients receive 2 courses of OEPA as in stratum 1 followed by 2 courses of COPDIC comprising oral prednisone on days 1-15, dacarbazine IV over 30 minutes on days 1-3, and vincristine IV and cyclophosphamide IV over 1 hour on days 1 and 8. Female patients receive 2 courses of OPPA as in stratum 1 followed by COPP comprising oral prednisone and 2 courses of oral procarbazine hydrochloride on days 1-15 and vincristine IV and cyclophosphamide IV over 1 hour on days 1 and 8. Both regimens repeat every 4 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Beginning 3 weeks after completion of chemotherapy, all patients undergo involved-field radiotherapy. * Stratum 3 (stages IIBE, IIIBE, or IV): Male patients receive 2 courses of OEPA as in stratum 1 followed by 4 courses of COPDIC as in stratum 2. Female patients receive 2 courses of OPPA as in stratum 1 followed by 4 courses of COPP as in stratum 2. Beginning 3 weeks after completion of chemotherapy, all patients undergo involved-field radiotherapy. PROJECTED ACCRUAL: A total of 648 patients will be accrued for this study.
Source references
Source notices and limitations
    Discovery and provenance
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        -fludeoxyglucose (18F-FDG) PET positive.</li><li>In the Gesellschaft f&#252;r P&#228;diatrische Onkologie und H&#228;matologie (GPOH) <a href="/clinicaltrials/NCT00416832">GPOH-HD-2002</a> study, nodal involvement was defined as node size greater than 2 cm in largest diameter. The node was not involved if it was less than 1 cm
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      source title
      Childhood Hodgkin Lymphoma Treatment (PDQ®)–Health Professional Version
      source update dates
      1. context
        Updated: April 16, 2025
        datetime
        2025-04-16T12:00:00Z
        display
        April 16, 2025

    Preserved source evidence · Not medical advice